ACTRN12619001556134招募中未知
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke (OPTIMISTmain): An international, stepped-wedge, cluster randomised clinical trial to determine whether less-intense monitoring is at least as effective (‘non-inferior’) to standard monitoring in the functional recovery of ischaemic stroke patients.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 7,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults (age more than 18 years);
- •Diagnosis of AIS and have been given intravenous (IV) bolus infusion of rtPA;
- •Clinically stable with mild-moderate neurological deficit (e.g. National Institutes of Health Stroke Scale [NIHSS] score less than 10) within 2 hours post IV tPA bolus dose in the opinion of the treating clinician
- •Provide informed consent (or via an appropriate proxy, according to local requirements) and remain in follow-up for 90 days
排除标准
- •Definite contraindication for less intense monitoring, in the opinion of the treating clinician( i.e needs monitoring of co-morbid conditions such as renal failure, palliative care, ICU admission);
- •Immediate transfer for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, hematoma evacuation) where adherence to less-intense monitoring is not possible.
研究者
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